Quick links to relevant pages on the TGA website
Guidance for Industry
- NEW: Factsheet: General requirements for advertising personalised medical devices to consumers
- Australian Dental Sector Working Group, Meeting statement, Meeting 4, 31 March 2022
- Therapeutic Goods Advertising Code: is the cornerstone of the therapeutic goods advertising regulatory framework. It sets out minimum requirements for advertising therapeutic goods to the public. Dated 29 November 2021
- Personalised medical devices landing page: The medical devices reforms page contains the regulatory changes and all the key links and updates.
- Global Medical Device Nomenclature (GMDN) Terms: Information to support sponsors and manufacturers.
- Custom-made medical devices landing page: Information for sponsors, health professionals and manufacturers. Updated 6 Oct 2022.
- Australian Register of Therapeutic Goods (ARTG). Search the ARTG to find if devices you currently use are already listed.
- FAQs: These Frequently Asked Questions cover many of the main areas of concern and confusion.
- Glossary of Terms: Search this for definitions of terms e.g. Manufacturer, Supplier, Active medical device.
- Inclusion Process: This is a step by step guide for Sponsors applying to include a 'kind of device' in to the ARTG
- An Overview of medical devices regulation: Information to assist you if you are new to the TGA and Australia's regulatory framework.
Guidance documents
- Submitting a custom-made medical device / patient-matched medical device transition notification Guide provided by the TGA. Dated August 2022
- TGA Database FAQ: outlines Frequently Asked Questions about the new improved TGA Database.
- Personalised medical devices (including 3D-printed devices): A guidance document for the new regulatory framework for PMD.
- Dental Sector Working Group's TGA submission.
Forms and tools
- Submitting a custom-made medical device / patient-matched medical device transition notification Guide provided by the TGA. Dated August 2022
- Classification Tool: Use this to help you decide what classification your device falls under.
- Is your Product a medical device? Work it out by using this tool.
